MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB; BREATHING CIRCUIT

Catalog Number 780-24

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2013

Event Type  malfunction  

Event Description

The event is reported, via fda letter with adverse event or product problem report.The customer alleges that the infant patient was on the ventilator using heated humidifier.After several days on the ventilator; it was noted that the infant circuit melted.The low pressure ventilator alarm was activated.The circuit was changed and no squeal noted.

Manufacturer Narrative

A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.The sample involved in the customer complaint was not returned for evaluation.However, an investigation was performed on material (780-24) from the production line.Based on the results of the dimensional analysis and the resistance evaluation analysis, no root cause can be identified since the tested parts were found within specification.In order to determine the root cause; the product involved in the complaint must be returned for investigation.The product ifu, states several warnings, not following any of these warnings could cause overheating the circuit that could generate a melted tubing.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.The customer complaint cannot be confirmed based only on the information provided.

• Brand Name: HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3952165
• MDR Text Key: 19971263
• Report Number: 3004365956-2014-00079
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VENTILATOR; CONCHA NEPTUNE: CAT #425-00
• Patient Outcome(s): Required Intervention